The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Velox Anterior Cervical Plate System.
Device ID | K131521 |
510k Number | K131521 |
Device Name: | VELOX ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SPINECRAFT LLC 777 OAKMONT LANE Westmont, IL 60559 |
Contact | Ami Akallal-asaad |
Correspondent | Ami Akallal-asaad SPINECRAFT LLC 777 OAKMONT LANE Westmont, IL 60559 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-28 |
Decision Date | 2013-12-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M824VVS245161 | K131521 | 000 |
M824VPH24601 | K131521 | 000 |
M824VPH23691 | K131521 | 000 |
M824VPH23661 | K131521 | 000 |
M824VPH23631 | K131521 | 000 |
M824VPH23601 | K131521 | 000 |
M824VPH23571 | K131521 | 000 |
M824VPH23541 | K131521 | 000 |
M824VPH23511 | K131521 | 000 |
M824VPH23481 | K131521 | 000 |
M824VPH23451 | K131521 | 000 |
M824VPH23421 | K131521 | 000 |
M824VPH23391 | K131521 | 000 |
M824VPH24641 | K131521 | 000 |
M824VPH24681 | K131521 | 000 |
M824VPH24721 | K131521 | 000 |
M824VVS245141 | K131521 | 000 |
M824VVS245121 | K131521 | 000 |
M824VVS240181 | K131521 | 000 |
M824VVS240161 | K131521 | 000 |
M824VVS240141 | K131521 | 000 |
M824VVS240121 | K131521 | 000 |
M824VPH24961 | K131521 | 000 |
M824VPH24921 | K131521 | 000 |
M824VPH24881 | K131521 | 000 |
M824VPH24841 | K131521 | 000 |
M824VPH24801 | K131521 | 000 |
M824VPH24761 | K131521 | 000 |
M824VPH22461 | K131521 | 000 |
M824VPH22441 | K131521 | 000 |
M824VPH22421 | K131521 | 000 |
M824VPH21161 | K131521 | 000 |
M824VPH21141 | K131521 | 000 |
M824VPH21121 | K131521 | 000 |
M824VPH21101 | K131521 | 000 |
M824VFS245181 | K131521 | 000 |
M824VFS245161 | K131521 | 000 |
M824VFS245141 | K131521 | 000 |
M824VFS245121 | K131521 | 000 |
M824VFS240181 | K131521 | 000 |
M824VFS240161 | K131521 | 000 |
M824VFS240141 | K131521 | 000 |
M824VFS240122 | K131521 | 000 |
M824VPH21181 | K131521 | 000 |
M824VPH21201 | K131521 | 000 |
M824VPH21221 | K131521 | 000 |
M824VPH22401 | K131521 | 000 |
M824VPH22381 | K131521 | 000 |
M824VPH22361 | K131521 | 000 |
M824VPH22341 | K131521 | 000 |
M824VPH22321 | K131521 | 000 |
M824VPH22301 | K131521 | 000 |
M824VPH22281 | K131521 | 000 |
M824VPH22261 | K131521 | 000 |
M824VPH22241 | K131521 | 000 |
M824VPH22221 | K131521 | 000 |
M824VPH21261 | K131521 | 000 |
M824VPH21241 | K131521 | 000 |
M824VFS240121 | K131521 | 000 |
M824VVS245181 | K131521 | 000 |
00193082001154 | K131521 | 000 |
00193082000997 | K131521 | 000 |
00193082000980 | K131521 | 000 |
00193082000973 | K131521 | 000 |
00193082000966 | K131521 | 000 |
00193082000959 | K131521 | 000 |
00193082000942 | K131521 | 000 |
00193082000935 | K131521 | 000 |
00193082000928 | K131521 | 000 |
00193082000911 | K131521 | 000 |
00193082000904 | K131521 | 000 |
00193082000898 | K131521 | 000 |
00193082000881 | K131521 | 000 |
00193082001000 | K131521 | 000 |
00193082001017 | K131521 | 000 |
00193082001024 | K131521 | 000 |
00193082001147 | K131521 | 000 |
00193082001130 | K131521 | 000 |
00193082001123 | K131521 | 000 |
00193082001116 | K131521 | 000 |
00193082001109 | K131521 | 000 |
00193082001093 | K131521 | 000 |
00193082001086 | K131521 | 000 |
00193082001079 | K131521 | 000 |
00193082001062 | K131521 | 000 |
00193082001055 | K131521 | 000 |
00193082001048 | K131521 | 000 |
00193082001031 | K131521 | 000 |
00193082000874 | K131521 | 000 |
00193082000867 | K131521 | 000 |
00193082000850 | K131521 | 000 |
00193082000690 | K131521 | 000 |
00193082000683 | K131521 | 000 |
00193082000676 | K131521 | 000 |
00193082000669 | K131521 | 000 |
00193082000652 | K131521 | 000 |
00193082000645 | K131521 | 000 |
00193082000638 | K131521 | 000 |
00193082000621 | K131521 | 000 |
00193082000614 | K131521 | 000 |
00193082000607 | K131521 | 000 |
00193082000591 | K131521 | 000 |
00193082000584 | K131521 | 000 |
00193082000706 | K131521 | 000 |
00193082000713 | K131521 | 000 |
00193082000720 | K131521 | 000 |
00193082000843 | K131521 | 000 |
00193082000836 | K131521 | 000 |
00193082000829 | K131521 | 000 |
00193082000812 | K131521 | 000 |
00193082000805 | K131521 | 000 |
00193082000799 | K131521 | 000 |
00193082000782 | K131521 | 000 |
00193082000775 | K131521 | 000 |
00193082000768 | K131521 | 000 |
00193082000751 | K131521 | 000 |
00193082000744 | K131521 | 000 |
00193082000737 | K131521 | 000 |
00193082000577 | K131521 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VELOX ANTERIOR CERVICAL PLATE SYSTEM 85821357 5592727 Live/Registered |
SpineCraft, LLC 2013-01-11 |